26 May 2024 marked a major regulatory threshold for laboratories across Europe using in-house manufactured IVDs (IH-IVDs). While some obligations of Article 5(5) of the IVDR have been in effect since May 2022 – most notably the requirement to comply with Annex I (GSPR); secondly ensuring the device is not manufactured on an industrial scale, and of course not transferring them to another legal entity – the majority of the more operational and documentation-heavy requirements kicked in exactly one year ago. 

That milestone triggered a profound change in how health institutions
must approach the development and use of their in-house tests. 

A Closer Look from Inside Health Institutions 

In the past year, diagnostic labs – especially within hospitals and public health systems – have been transitioning from less formalized and standardized internal practices to a more structured, traceable, and justified use of IH-IVDs. Since 26 May 2024, the following elements have become enforceable: 

• Implementing a suitable QMS (ISO 15189 or equivalent) 

• Preparing for potential review by Competent Authorities, including getting audited, and registering the IH-IVDs in some countries 

• Having detailed documentation available on request, covering the whole life cycle of an IH-IVD, including design, performance, risk, clinical justification and clinical use experience review 

These requirements go well beyond the initial GSPR compliance and have added new dimensions of regulatory responsibility for clinical laboratories. 

The obligation to provide clear justification that no equivalent CE-marked device is available is only enforceable starting 31 December 2030. This means labs are not yet required to prove the non-availability of a CE-marked equivalent — but they will need to prepare for this in the coming years. 

Field Insights: Where We Are After One Year 

1. Awareness is growing, but uneven 
   Larger university and international labs are often well into the compliance process, but sometimes struggling with the harmonization and streamlining of solutions. On the other hand, many mid-sized and smaller institutions are just now realizing the full scope of what’s expected. 

2. Lack of resources is a major blocker — Many labs operate with limited personnel, part-time contracts, and no dedicated regulatory staff. The budget for external consulting is often very limited. Quality and documentation tasks are often done on top of clinical routine, carving out time for bench work and without the time or support they truly require. These are exactly the settings where smart, structured support makes the biggest difference. 

3. Documentation remains a sticking point 
   Most labs are not accustomed to preparing regulatory-style documentation for in-house work. Terms like “risk control measures” or “performance evaluation” are still new territory. But: without appropriate documentation, or with insufficient or incomplete documentation only, the laboratory does not meet its legal requirements. This can have serious consequences. 

4. The “equivalence” debate is unresolved 
   Labs are expected to demonstrate why no CE-marked equivalent device is available. But what qualifies as equivalent? MDCG 2023-1 propagates a justification of non-equivalence based on technical, biological or clinical aspects of the device; but this leaves a lot of room for interpretation. And what evidence is sufficient? And how do you document it? These are ongoing points of discussion – and divergence – between labs and regulators. 

5. Competent Authority practices vary 
   While some Member States have provided clear guidance and registration portals (e.g. Belgium, Ireland), others have been relatively silent. Even the requirements are interpreted differently at the local level. This leads to uncertainty and fragmentation, especially for international clinical testing service providers operating labs in multiple EU countries. 

6. Innovation is slowed – but not stopped 
   Labs remain committed to innovation, particularly in response to urgent diagnostic needs. But there’s a growing concern: will regulatory overhead choke the flexibility labs need to serve patients? 

Moving Forward: What Labs Need Now 

• Leadership commitment and strategic direction: The push for IVDR compliance must come from the top. Laboratory directors, heads of institutions, and hospital management need to provide clear priorities, dedicated resources, and ideally a structured solution to steer teams through the transition. Without visible leadership, compliance remains a siloed side task.  
  
• Interpretive guidance: Clearer definitions from regulators – especially on terms like “industrial scale” and “equivalence” – are essential. 
  
• Practical implementation tools: Labs need more than legal texts. They need smart, structured templates, checklists, and ideally digital tools to support compliant documentation without excessive manual work. 
  
• Community & knowledge sharing: Peer support and shared best practices are among the most effective ways labs are currently navigating this transition. More platforms for exchange are needed. 

Closing Thoughts 

The IVDR’s aim is to ensure high-quality diagnostics, safety, and traceability – even in the in-house environment. But achieving this must be practical and proportionate for labs already stretched by clinical demands. 

As we reflect one year into full Article 5(5) enforcement, we’re starting to see both the positive shifts in quality thinking and awareness – and the real gaps in feasibility, staffing, audit readiness and support. 

Now is the time to listen to the labs, refine implementation, and ensure the regulation supports – not hinders – Europe’s diagnostic excellence. 

To help with these challenges, our software solution PlatoX® at @Platomics supports laboratories by automating key parts of the Article 5(5) documentation process – from crafting the intended purpose statement, risk classification, handling GSPRs, doing risk management and validation documentation, to finally get to the public declaration needed. This not only reduces manual workload but enables faster, more structured compliant documentation on diagnostic tests. 

What’s been your experience with Article 5(5) so far?
We would love to hear from lab professionals!

*We have compiled the above information to the best of our knowledge, yet our blog entries do not constitute expert advice and cannot substitute your own examination of the legal situation applicable to you and your institution.